# K083005: Nangel

- Pathway: 510(k) (Traditional)
- Applicant: Teknimed, S.A.
- Decided: Mar 4, 2009 after 147 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
HYDROXYLAPATITE GEL is designed as a material intended for filling osseous defects not intrinsic to bone stability. HYDROXYLAPATITE GEL is progressively reabsorbed and replaced by bone during the rehabilitation process. The use of HYDROXYLAPATITE GEL is recommended for: Dental or maxillo-facial surgery: - Filling after surgical curettage (cysts or benign tumors) - Osseous defects caused by a traumatic bone lesion. - Treatment of alveolar wall and crest defects

Source page: https://510kreport.com/device/K083005
Methodology: https://510kreport.com/methodology